Opioid Education in Total Knee Arthroplasty

December 23, 2024 updated by: Hospital for Special Surgery, New York

Effect of Perioperative Opioid Education on Outcomes After Total Knee Arthroplasty: A Randomized Study

The goal of this experimental study is to compare different education intervention on opioid education for patients undergoing total knee arthroplasty. The specific research questions to address are:

  1. Does perioperative education pathway reduce opioid refill requests?
  2. Is education pathway that focuses on pain management provided in-person and via video in repeated sessions more effective than current standard of care education consisting of a single exposure given as part of a broader preoperative presentation covering multiple topics?
  3. Is there a difference between education provided in-person vs video?
  4. Does perioperative education improve compliance with multimodal analgesia?
  5. Does perioperative education improve appropriate opioid storage?
  6. Does perioperative education improve appropriate opioid disposal?

Enrolled patients will be assigned at random to one of 3 study groups. Group 1 (control): Patients are referred to the hospital's standard 1-hour virtual patient education webinar prior to surgery.

Group 2 (in-person): Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive portable document format (pdf) handouts about opioid and pain management.

Group 3 (video): Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioid and pain management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing surgery are frequently unaware of how to properly use opioids for pain management which may result in poor compliance with pain regimens, worse pain control and functional outcomes, and improper storage and disposal. There is evidence that educational interventions in various formats may improve pain and promote proper opioid handling. In addition, multimodal analgesia has been shown to be effective in total joint arthroplasty, and setting appropriate expectations may reduce anxiety, postoperative recovery time, and post surgical acute pain.

The current education process at HSS involves patient referral to a virtual webinar which is optional. Pain topics are covered within a broader 50-minute presentation on numerous topics related to surgery. Information on pain topics may be difficult to process and retain because it is a single exposure that is combined with multiple unrelated topics, and there is no repetition or reference provided. The aim of this study is to explore how a comprehensive educational pathway focusing on aspects of pain control and proper opioid use with repeated sessions will affect outcomes after total knee arthroplasty by comparing three groups - 1) patients who attend the virtual webinar, 2) an in-person session with a portable document format (PDF), and 3) a video session with PDF.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between age 18 and 80 years old
  • Undergoing primary total knee replacement surgery at Hospital for Special Surgery
  • English speaking

Exclusion Criteria:

  • History of chronic opioid use (continuous opioid use for 3 or more months)
  • Opioid use within the past 3 months
  • Contraindication to NSAIDs or acetaminophen
  • Contraindication or allergy to opioids
  • Contraindication to any study medications (i.e., fentanyl, ketamine, versed, acetaminophen, ketorolac, zofran, decadron)
  • Discharge to rehab or skilled nursing facility (opioids are not prescribed by HSS providers)
  • Contraindication or refusal to receive neuraxial anesthesia or peripheralnerve blocks (PNB)
  • Revision surgery
  • Ambulatory surgery
  • Patients who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients are referred to the Hospital's standard 1-hour virtual patient education webinar prior to surgery.
Experimental: In-person and PDF
Patients will receive two in-person education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Other: Opioid education in person

The presentation and handouts contain information regarding the following topics:

  • Reviewing opioids and strategies for analgesia

    • Defining and identifying opioids
    • Goals for postoperative pain management and utilizing opioids to treat pain
    • Alternative modes of treating pain
    • Regional anesthesia/analgesia defined

  • Side effects and risks of opioids

    • Common side effects of opioids
    • Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use

  • Proper use and handling of opioids

    • Safe practices when taking opioids
    • Weaning off opioids
    • Safe storage and disposal of opioids
Experimental: Video and PDF
Patients will receive two video education sessions (1st session before surgery and 2nd session after surgery). Patients will also receive pdf handouts about opioids and pain management.
Other: Opioid education via video

The video and handouts contain information regarding the following topics:

  • Reviewing opioids and strategies for analgesia

    • Defining and identifying opioids
    • Goals for postoperative pain management and utilizing opioids to treat pain
    • Alternative modes of treating pain
    • Regional anesthesia/analgesia defined

  • Side effects and risks of opioids

    • Common side effects of opioids
    • Risks of addiction, tolerance, dependence, opioid-induced hyperalgesia with long-term use

  • Proper use and handling of opioids

    • Safe practices when taking opioids
    • Weaning off opioids
    • Safe storage and disposal of opioids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid refill at POD 30
Time Frame: Post operative day (POD) 30
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Post operative day (POD) 30
Opioid refill at POD 60
Time Frame: Post operative day (POD) 60
Patients will be asked if they have refilled their opioid prescription and the number of opioid refills.
Post operative day (POD) 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week)
The total amount of time spent in-patient following their surgery.
From the time patient enters the post-anesthesia care unit (PACU entry) until the time patient is discharged from the hospital (discharge time), assessed up to 168 hours (1 week)
Patient's health and recovery status following their surgery
Time Frame: Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14

A survey titled: quality of recovery 15 (QoR15) is a patient- reported outcome measure measuring quality of recovery after surgery and anesthesia.

Each of the following question on the survey will be assessed on a 0-10 scale, with 0 meaning "none of the time" and 10 meaning "all of the time".

How have you been feeling in the last 24 hours?

  1. Able to breathe easily
  2. Been able to enjoy food
  3. Feeling rested
  4. Have had a good sleep
  5. Able to look after personal toilet and hygiene unaided
  6. Able to communicate with family or friends
  7. Getting support from hospital doctors and nurses
  8. Able to return to work or usual home activities
  9. Feeling comfortable and in control

  10. Having a feeling of general well-being

    Have you had any of the following in the last 24 hours?

  11. Moderate pain
  12. Severe pain
  13. Nausea or vomiting
  14. Feeling worried or anxious
  15. Feeling sad or depressed
Pre-operative (when patient is in the holding area being prepped for surgery), Post-operative day 1, Post-operative day 7, Post-operative day 14
Numerical Rating Scale
Time Frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Patients are asked to report a number between 0 and 10 that best measures their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Opioid consumption
Time Frame: Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
The amount of opioid consumption by the patient (in oral morphine equivalents).
Post-operative day 0, Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of compliance with multimodal regimen
Time Frame: Post-operative day 1, Post-operative day 7, Post-operative day 14
Patients will keep "pain diary" to record use of each medication (acetaminophen, NSAIDs, and opioid). Compliance will be defined as the percentage of prescribed medication (acetaminophen or NSAID) that is actually taken.
Post-operative day 1, Post-operative day 7, Post-operative day 14
Rates of proper opioid storage
Time Frame: Post-operative day 7
Patients will be asked to report how they are storing their opioids (i.e., stored "locked and hidden").
Post-operative day 7
Rates of proper opioid disposal
Time Frame: Post-operative day 21
Patients will be asked to report how they are disposing of their unused opioids (i.e., reporting they dispose using one of the accepted proper disposal methods).
Post-operative day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Bradley H Lee, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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